Dare Bioscience Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 13, 2025

Key Takeaways

  • Dare has adopted a dual path strategy to rapidly commercialize proprietary formulations via FDA-regulated 503B compounding while continuing to pursue traditional FDA approval and launch certain products as over-the-counter consumer health brands.
  • The company expects to record its first commercial revenue from the Sildenafil Cream in Q4 2025, and plans to launch two vaginal probiotics in 2025 and a monthly intravaginal hormone therapy in 2026, targeting the ~$4.5 billion compounded hormone therapy market.
  • In Q1 2025, Dare reported a comprehensive loss of ~$4.4 million, ended with $10.3 million in cash and equivalents, and had a working capital deficit of approximately $9.4 million.
  • Enrollment in the pivotal Phase III study of Ovaprene, the hormone-free monthly contraceptive, is ongoing with a July 2025 Data Safety Monitoring Board safety review and is supported by up to $10.7 million in non-dilutive grant funding.
  • Dare plans to submit its Phase III protocol and statistical analysis plan for the Sildenafil Cream development program by end of Q2 2025 following FDA feedback on patient-reported outcome measures, and is advancing DARE HPV toward a Phase II study with up to $10 million in award funding.
AI Generated. May Contain Errors.
Earnings Conference Call
Dare Bioscience Q1 2025
00:00 / 00:00

Transcript Sections

Skip to Participants
Operator

Welcome to the conference call hosted by Daré Bioscience to review the company's first quarter 2025 financial results and to provide a business update. This call is being recorded. My name is Gayle, and I will be your operator today. With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer, and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

MarDee Haring-Layton
Chief Accounting Officer at Daré Bioscience

Good afternoon, and welcome to the Daré Bioscience financial results and business update call for the quarter ended March 31st, 2025. Today, we will review our results, discuss developments and expectations for our pipeline and portfolio, and discuss our recently announced expanded business strategy, leveraging a dual-path strategy where we commercialize our proprietary formulations via 503(b) compounding while continuing to seek FDA approval, as well as taking steps toward launching certain solutions as branded consumer health products that do not require a prescription, in all cases to bring solutions to market as soon as practicable. I would like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

MarDee Haring-Layton
Chief Accounting Officer at Daré Bioscience

Any statements made during this call that are not statements and historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31st, 2025, which was filed today, and our Form 10-K for the year ended December 31st, 2024. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, May 13, 2025. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I will now turn it over to Sabrina.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Thank you, and thank you everyone for joining the call today. We're excited to announce today that in addition to our proprietary Sildenafil Cream formulation, we are taking action to make three more solutions for women available commercially: two vaginal probiotics in 2025 and our proprietary monthly hormone therapy in 2026. Making our hormone therapy solution available next year creates a commercial opportunity for Daré in the estimated up to $4.5 billion compounded hormone therapy market and enables women to have access to an evidence-based solution. As you can appreciate, four on-market products will accelerate revenue generation and provide a path to profitability. We expect to start recording revenue in the fourth quarter of this year. Anyone following the healthcare and biotech sectors knows that the first quarter of 2025 has been marked by distractions and disruptions for the overall healthcare and biotech sector.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

I'm proud that Daré is uniquely positioned to cut through the noise and deliver value to all of our shareholders, women, healthcare providers, and investors who are all stakeholders in Daré. Today, biopharmaceutical companies with relatively low-risk assets, a competitive advantage, and a path toward near-term revenue are positioned to offer upside. We believe that is Daré today. Women's health is ripe for returns because it has been underfunded and fragmented. With our recently announced expanded business strategy, we believe we are strongly positioned to deliver value and returns to all of our stakeholders with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels. We're no longer only seeking FDA approval. We're leveraging a dual-path strategy where we commercialize via 503(b) compounding while continuing to seek FDA approval.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We're also taking steps towards launching certain solutions as branded consumer health products that do not require a prescription. At Daré, women's health isn't just a priority. It's our sole purpose. To our knowledge, we are the only publicly traded company focused solely on developing therapeutic products for a broad range of conditions affecting women: contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause. To our knowledge, we're the only publicly traded company leveraging all available paths to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care: as an FDA-approved treatment, as a compounded product, as a consumer health product that does not require a prescription, available via telehealth, online, or via an in-person visit with her healthcare provider.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Our portfolio is compelling, and over the last months and the next months, we look forward to continuing to provide updates regarding strategic partnerships and collaborations to facilitate access to Daré on-market brands for women across multiple channels. Today, I'll provide some perspective on these channels and the strategic relationships we're seeking to enter into to provide women with access to our evidence-based solutions from their trusted sources, where they get their medication and their healthcare solutions. I'll also provide a refresher on our potential first-in-category monthly intravaginal hormone therapy, a product candidate we've been developing to really shift the hormone therapy landscape. Gaps in solutions for menopause symptoms have given rise to an explosion of untested supplements and therapies. We believe in delivering hormone therapy that has been rigorously studied to meet the needs of women and their doctors.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Please keep in mind that bringing our proprietary Sildenafil Cream formulation and our monthly intravaginal hormone therapy solution to market via 503(b) compounding will not impact the regulatory process or commercial opportunity for an FDA-approved product. Rather, if successful, it accelerates the availability of these proprietary formulations for healthcare providers and women, and it accelerates revenue. It can also provide real-world evidence and experience that we would seek to utilize to streamline the path to an FDA approval of these potential first-in-category candidates. I'll also give some background on the vaginal probiotics that we also intend to bring to market this year, both of which, by the way, were identified via a grant we received from the Gates Foundation to evaluate the global probiotic manufacturer community and identify evidence-based formulations from manufacturers following GMP.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

I'll also give a brief update on Ovaprene, our novel investigational hormone-free monthly intravaginal contraceptive, the ongoing enrollment in the pivotal phase three contraceptive efficacy study, and our Data Safety Monitoring Board interim assessment, which is scheduled for July of this year. As well as other therapeutic development pipeline updates on Sildenafil and DARE-HPV, which is our investigational product for the treatment of human papillomavirus infection, which is the virus that causes cervical cancer. Before I provide additional updates, I'm going to first turn it back over to our Chief Accounting Officer, MarDee Haring-Layton, to review first quarter 2025 financial results.

MarDee Haring-Layton
Chief Accounting Officer at Daré Bioscience

Thanks, Sabrina, and thanks everyone for joining us today. I would now like to summarize Daré's financial results for the quarter ended March 31st, 2025, which I will refer to as the first quarter. Put simply, Daré's business strategy is to assemble and advance a portfolio of differentiated treatment solutions that address meaningful unmet needs we've identified in women's health, and then to monetize the value of our portfolio's clinical and regulatory advances over the near and long term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses. During the first quarter of 2025, our general and administrative expenses were approximately $2.3 million, which is a 14% decrease compared to Q1 2024, due primarily to reduced stock-based compensation expense, reduced professional services expense, and reduced headcount.

MarDee Haring-Layton
Chief Accounting Officer at Daré Bioscience

We continue to maintain a lean and focused team and are managing overhead costs closely. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other development program costs, were approximately $2.3 million, which is a 31% decrease compared to Q1 2024. Our comprehensive loss for the quarter was approximately $4.4 million. We ended the first quarter with approximately $10.3 million in cash and cash equivalents and a working capital deficit of approximately $9.4 million. Daré remains committed to being creative, collaborative, and opportunistic to build shareholder value, including by making certain proprietary formulations in the Daré portfolio accessible via a prescription through the FDA's 503(b) pathway. As of May 12, 2025, we had approximately 8.9 million shares of common stock outstanding.

MarDee Haring-Layton
Chief Accounting Officer at Daré Bioscience

We encourage investors to review the more detailed discussion of our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended March 31, 2025, filed today. I would now like to turn the call back over to Sabrina.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Thank you. As we all know and we've been discussing, we are a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Our vision is to meet the increasing demand for evidence-based treatments with both uncompromising scientific rigor and rapid, responsible commercialization. As a leader in women's health, we continuously hear from the healthcare providers and women themselves about the urgent need for faster access to trusted, evidence-based treatments that women can afford. We believe that innovation does not have to start from scratch. Solutions that can address decades of unmet needs in women's health often already have clinical proof of concept or existing safety data for the active ingredient. We seek to leverage these data and insights in order to bring solutions to market rapidly in a fiscally responsible manner and in ways designed to optimize access for women.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting, but access to real, evidence-based solutions still lags behind. As awareness grows, so does the demand for treatment options, and we are seeking to meet this moment by ensuring women have access to solutions that are not only needed but are evidence-based. Like our Sildenafil Cream formulation, our investigational hormone therapy, DARE-HRT1, is being developed in response to feedback from women and their healthcare providers. Specifically, despite the fact that the Menopause Society recommends hormone therapy and recommends delivering estrogen and progesterone together for women with intact uteri, and despite the fact that the Menopause Society states that non-oral routes of administration may offer potential advantages, there is no non-oral hormone therapy that meets those criteria that a woman can administer directly. DARE-HRT1 is just that.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

It's an intravaginal ring that a woman can self-administer just once a month. Like our Sildenafil Cream formulation, DARE-HRT1 has been evaluated in rigorous toxicology studies and completed pharmacokinetic studies demonstrating the systemic levels of the hormones being administered, as measured in the blood of postmenopausal women. Our clinical study findings specific to this proprietary formulation have been published in peer-reviewed journals. Making our hormone therapy solution available next year via 503(b) compounding creates a commercial opportunity for Daré, as I mentioned, in the estimated up to $4.5 billion compounded hormone therapy market and enables women to access this evidence-based solution. As with the menopause sector, gaps in solution in the vaginal health sector have similarly led to an explosion of untested supplements and therapies.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

The two vaginal probiotics that we also intend to bring to market this year, as I noted upfront, were identified via a grant we received from the Gates Foundation last year. It was a grant to evaluate the global probiotic manufacturer community and to identify evidence-based solutions and formulations for manufacturers following GMP. These two products were designed to restore a healthy vaginal microbiome and have been evaluated and demonstrated effective in clinical studies in women outside of the U.S. in restoring a healthy vaginal microbiome, but they are not yet available here. We want women in the U.S. to also have access to these evidence-based vaginal probiotics, and we intend to make them available as branded consumer health products later this year.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

This is a good place for me to address the strategic partnerships and collaborations we intend to establish to facilitate access to Daré's on-market brands for women across multiple channels, for both the prescription products via 503(b) compounding and branded consumer health products. As I stated at the beginning of the call, our goal is to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care. As I mentioned, that might be an FDA-approved treatment, a compounded product, a consumer health product that does not require a prescription, might be available via telehealth, other online platforms, via an in-person visit with your healthcare provider. We want women to access these products, these Daré on-market brands, from the source they trust and that reflects where and how they are currently selecting their solutions and getting their care today.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

What does that mean in terms of our partnering strategy? It means partnering with telehealth providers that reflect Daré's mission of challenging the status quo and putting women's health first, and that are committed to providing evidence-based solutions. It means partnering with online retailers that provide complementary offerings. It means collaborating with online prescription fulfillers so that our formulations are available on their platforms. It means participating in medical conferences and continuing medical education programs so that the healthcare community is broadly aware of these evidence-based solutions as they consider their treatment guidelines. Put simply, it means meeting women where they are, wherever they are. Therefore, do not expect just one strategic partnership. Expect several.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

The delivery of healthcare and the purchase of healthcare solutions has changed dramatically over the last five years, and we would not be true to our corporate tagline, which is "Daring to be different," if we did not lean into the latest trends in accessible healthcare and put partnerships and collaboration in place that reflect those trends. Finally, I should also note that like our Sildenafil Cream and our monthly intravaginal hormone therapy formulations, there are other proprietary formulations in the Daré portfolio that we can make accessible via prescription through the 503(b) pathway. We are actively evaluating the dual-path approach for some of our other proprietary formulations. That dual path, again, is to continue to pursue FDA approval of a product candidate for a treatment indication while simultaneously bringing that formulation to market via the 503(b) pathway as soon as practicable.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We're taking this approach as part of our responsibility to women, to the healthcare community, and to our shareholders, and because we believe women should not have to wait for needed medical treatment solutions while they continue to pursue an FDA-approved path. Over the next months, we'll continue to provide additional updates, so please stay tuned. I'm now going to talk through our anticipated 2025 milestones for our therapeutic product candidates. I'll highlight Ovaprene, Sildenafil Cream, and DARE-HPV in that regard. Ovaprene, again, is our novel investigational hormone-free monthly intravaginal contraceptive whose commercial rights are under a license agreement with DARE Healthcare. Enrollment is ongoing in the pivotal phase three contraceptive efficacy study of Ovaprene. Recall that we announced an up to $10.7 million foundation non-dilutive grant in November 2024, which supported the addition of five new investigator sites in the first quarter of this year.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We've been really pleased with the pace of enrollment at those sites to date, but I will say, don't ask me because it's too early for me to predict enrollment rate for the remainder of the study. I will share, though, that we do not anticipate that the NICHD, those NIH contracted study sites, will resume enrolling new participants under their existing NIH contracts. Review of the interim data by the Data Safety Monitoring Board, which is an independent group of experts that evaluates the safety and integrity of the study, is scheduled for this July, July 2025, and we will provide an update following that meeting. Recall overall that the primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated Pearl Index for Ovaprene.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Secondary objectives are to assess Ovaprene's 13-cycle use cumulative pregnancy rate, safety, acceptability, product fit and ease of use, and assessments of vaginal health. If successful, we expect the study to support the submission of a pre-market approval application for Ovaprene to the FDA, as well as regulatory filings in Europe and other countries worldwide to allow marketing approvals of Ovaprene. Regarding Sildenafil Cream as an investigational cream formulation of sildenafil, which is the active ingredient in the oral erectile dysfunction drug for men, for topical on-demand administration to treat female sexual arousal disorder, we have continued our interactions with the FDA regarding the planned phase three study and expect more updates on phase three design, development, and collaboration strategy throughout 2025.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We're targeting submission of additional information requested by the FDA, along with the protocol and the statistical analysis plan for the phase three study, to get those to the FDA by the end of the second quarter of 2025. That's really our immediate next step on this development program on our path to pursuing an FDA approval. For DARE HPV, I will remind that in 2024, we were selected to receive an award of up to $10 million for the development of DARE HPV, which is an innovative investigational treatment for HPV-related cervical diseases. With the support of that funding, we're advancing DARE HPV towards a phase two clinical study, which is supported with that funding. Essentially, all cervical cancer cases worldwide are caused by HPV infection.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Despite the fantastic advancement in HPV screening and vaccination in the U.S., an estimated 100,000 women are still treated for cervical precancer each year, and an estimated 4,000 women are expected to die from cervical cancer in 2024. Today, cervical precancers are monitored until they reach a late stage, since the most common treatment is surgery, which removes parts of the cervix. That surgery is associated with an increased risk of preterm birth and sexual dysfunction, so it's not recommended for patients with fertility concerns. In the U.S., about 10% of women with HPV infection on the cervix will develop long-lasting HPV infections that put them at risk for cervical cancer.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

DARE HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both genital HPV infections in women as well as late-stage cervical dysplasia and treat that infection, which would change the paradigm around how HPV-related cervical diseases are clinically managed today, preventing surgery, stopping the spread, and transforming care for this critical health issue. DARE HPV is reflective of the type of development program we really like to advance at Daré. It's a first-in-category product, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections. Specifically, DARE HPV is an investigational proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, with the potential to be this first-in-category treatment for HPV infection and HPV-related cervical diseases.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We look forward to continuing to execute activities necessary to enable submission of the IND application to the FDA and for a phase two randomized placebo-controlled double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women, all supported with the funding we receive under that $10 million award. We're excited to be able to provide more updates in the coming months on our therapeutic development programs, as well as our progress as we work to commercialize some of the most potentially disruptive candidates for the health and well-being of women in decades. I'd like to now turn the call over to the operator for Q&A.

Operator

Thank you, Sabrina. At this time, I would like to remind everyone that in order to ask a question, press star and then the number one on your telephone keypad.

Operator

We will pause for just a moment to compile the Q&A roster. We see your first question comes from the line of Douglas Chow with HC Wainwright. Please go ahead.

Douglas Chow
Douglas Chow
Analyst at HC Wainwright

Hi, good afternoon, and thanks for taking the question. I guess, Sabrina, you said that we should anticipate several different partnerships in terms of sort of the compounded distribution of products. I'm just curious, would that be unique partnerships for each product, or could you potentially have multiple partnerships for an individual product?

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Yeah, that's a great question. Thanks for asking for the clarification. Both.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

First of all, I want to start out that we would intend to have multiple partnerships for an individual product because we want to make sure, as I mentioned, that that product is available in as many places as possible that makes sense in terms of where women are getting their care and that, like I said, meet our objectives in terms of criteria around that platform having the right commitment and the right access to women on their platforms and where they might have complementary products as well. For an individual product, absolutely expect several relationships to support that brand, having as wide access as possible and as it makes sense for that particular product and that particular channel being supported.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

But also, as I think may be intuitive, but just in case it's not, these platforms that have built fantastic relationships with the patients and consumers that use their platforms, obviously, it's very compelling for them to have access to new products and especially evidence-based treatments and opportunities to partner with Daré, which is a leading pharmaceutical developer in the area of women's health. There are also interesting opportunities where multiple Daré products could be available on an individual platform as well. Over the coming, as I said, over the coming months, expect more news from us around this, more announcements around this. The goal is to very simply make sure that these evidence-based treatments are available for the women who are seeking them and for the healthcare providers that want to provide them.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

That means we want to make sure they are on as many platforms and via as many channels as possible. That is what the relationships and collaborations and partnerships will reflect.

Douglas Chow
Douglas Chow
Analyst at HC Wainwright

I guess I'm just curious, when you think about, and this is maybe specific to Sildenafil Cream, target being sort of in the market by the end of the year, is there much that you need to do to ensure that there is sufficient manufacturing capacity for the product by year-end?

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Another great question. We definitely want to make sure that our 503(b) collaborator on this. Under 503(b), just taking a step back for a second for everyone's benefit, under 503(b), the product, the statute, the product needs to be manufactured at a registered 503(b) facility.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Therefore, we need to support our 503(b) facility in how to make our proprietary Sildenafil Cream, right, get them ready. This is GMP manufacturing. This is not compounding at a pharmacy. This is at an outsourcing facility, which are regulated by FDA's GMP rules and subject to FDA inspection. Therefore, there are activities that need to happen for that manufacturer to be prepared to provide the product at the scale that we need. That's why it's fourth quarter and not yesterday that we were launching this product. That's really what that timing is for.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

In addition to that, though, what that gives us is some nice time between now and then to do a lot of work around provider education and medical education with the support of the medical institutions that are very focused on sexual health of women and other platforms that are focused on education of providers that are focused in that field. What it allows us to do in terms of other preparations is to use this time to make sure that we're supporting those providers with education around disease state and also education around our specific Sildenafil Cream formulation.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Those are really the three key sets of activities that are happening between now and this product being commercially available. One, supporting our 503(b) manufacturer with all the support they need to make sure they're up and running, to your point, at the scale that we want to support this exciting brand. Two, it's the partnerships and collaborations that we've been talking about to ensure the availability of the product in multiple channels and platforms. The third is that provider education. A group of us are going to be at ACOG at the end of this week, which is the American College of Obstetrics and Gynecology Conference. It is the first time Daré has a booth at the conference. We are there for education and to provide some education around what Daré is doing and what's coming soon from our portfolio.

Douglas Chow
Douglas Chow
Analyst at HC Wainwright

Sabrina, if I can, one more. I'm just curious because I think you've been talking to potential partners around Sildenafil Cream in terms of the sort of traditional FDA-approved track. I'm curious if you've gotten feedback from potential partners and reaction broadly from others in the sort of traditional pharmaceutical industry to you taking this step. Thank you.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Yeah, we definitely have. I would say the feedback has been fantastic and complimentary in terms of our really being open-minded and thoughtful and creative in how we get this product out there as quickly as possible. Everyone recognizes in pharma more than anyone that drug development can take a very long time, right, decades in some cases.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We have received a lot of super positive feedback from the industry and those players in terms of how we have found a way to accelerate getting a product to market that healthcare providers are anxious to have, so that women are not waiting and they can actually get something that is evidence-based and has been studied for a condition for which they are seeking an option. The feedback has really been very, very positive. It is definitely part of, frankly, what has inspired us to really look more broadly across our portfolio: the feedback from the healthcare providers, the feedback from women, and importantly, the feedback from our peer drug developers.

Douglas Chow
Douglas Chow
Analyst at HC Wainwright

Okay, great. Thank you so much. I will jump out of the queue.

Operator

Your next question comes from the line of Katherine Novak with Jones Research. Please go ahead.

Operator

Hello. Hi, Sabrina. This is Leona on for Katherine.

Operator

Thank you for taking our questions. I'll just start with Sildenafil phase three. What additional information has the FDA requested? For Ovaprene, can you provide any additional information on the potential outcomes of the interim assessment? Will you have the opportunity to increase the sample size if needed?

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Yeah, both great questions. Starting with Sildenafil, to put that in context. In April, we received additional input and information requests from the FDA regarding our patient-reported outcome psychometrics. I don't expect everyone to know what psychometrics means. Basically, it's about your questionnaires, the test retails reliability, is it content valid or fit for purpose. These are specific terms that are used around patient-reported outcomes and specifically related to both what was done in the phase two, but also importantly, what should be done in phase three as part of that overall final validation.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

That's something, by the way, that was anticipated to be part of the phase three plan and had been discussed with the FDA. As you can appreciate, this psychometric analysis has bearing on the efficacy endpoint and also the statistical analysis plan and just what's included in the phase three study. We've submitted information to the FDA in response to this. We're targeting submission of additional requested information along with the actual protocol incorporating that and the statistical analysis plan for the phase three incorporating that to the FDA. We're targeting by the end of this quarter. That's why I say this is, while we would like to target commencement and are targeting commencement of the phase three study this year, that's really pending us getting this into the FDA and then obviously their review.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Then any additional feedback we might get in response to this because obviously, we want the phase three trial that is ultimately conducted to be very clearly reflective of everything the FDA needs to see in it in order for it to be supportive of registration. Then in terms of Ovaprene and the Data Safety Monitoring Board meeting that's scheduled for this July, as the name implies, it is a safety meeting. They're really looking at the safety and the integrity of the study. That's what their charter requires them to do. In terms of it's not an analysis and a planned review for sample size, that's not their goal. In fact, there will not be any statistical assessment of the primary endpoint of the study.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

That is the kind of thing that would be needed if there was going to be a sample size change. It is really just looking at safety. Now, having said that, and I have said this a few times, which I think is sometimes surprising to people, but two things. One, this is an open-label study. It is open-label. Everyone is on Ovaprene. Two, a pregnancy in a contraceptive study is considered an adverse event. They will be looking at those data in that context, but there will be no assessment of the actual Pearl Index, which is the primary endpoint in the study. There is no opportunity, therefore, to do any kind of sample study size changes based on that because there will not be any assessment at the primary endpoint.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Great. Thank you so much. If I could just ask a couple more add-on.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Sure.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

For the compounding drugs, are you pursuing a dual path for all four of those products? Oh, great question. Yep. Go ahead. I guess you've kind of answered this, but what kind of marketing and KOL outreach are you doing for the ones that were mentioned today, the probiotics and then the hormone therapy?

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Yeah. To clarify, Sildenafil and the hormone therapy are both dual-path products. They're a prescription. They'll be available via compounding under 503(b) statutes as a prescription. We are pursuing a dual path in that we are continuing our efforts and activities to support ongoing development of those products through, for both of them, it would be the 505(b)(2) regulatory pathway to get a treatment indication. For the vaginal probiotics, those are consumer health brands.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

For products of that nature, while one could certainly choose to pursue an FDA approval for products of that nature to get some sort of treatment claim if they wanted, we're not interested in that. These are really products designed to restore a vaginal microbiome. That is not necessary. There's no other work we're going to be doing on those other than making those available in the United States. In terms of efforts to kind of educate and support, the primary effort right now on the part of Daré is very much focused around Sildenafil. There will be more efforts on the hormone therapy next year. The good news is it's all the same KOLs and it's all the same medical societies that really focus on both sexual health and menopause.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We will be focusing on education programs right now around Sildenafil and its availability. We are also doing a lot to raise awareness around Daré and what we are doing as a leader in ensuring that these evidence-based treatments make it to women and making sure that the healthcare providers are educated on them. That will really be our focus in the near term, a lot of focus around Sildenafil. As we get into next year, even more focus on the hormone therapy as well. Obviously, we are making the consumer health brands, which is a little bit of a different channel, although we do think that there are a lot of healthcare providers that are very interested in having an actual evidence-based solution that they can make available to their patients. We will opportunistically make sure that they are educated on those as well.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Great.

Operator

Thank you so much. Yeah. Once again, if you would like to ask a question, press star one on your telephone keypad. Please say your next question comes from the line of Ollie Heidel with Brookline Capital Markets. Please go ahead.

Ollie Heidel
Analyst at Brookline Capital Markets

Hey, Sabrina. Quick question regarding Ovaprene, the trial. Does the grant received in November cover costs to add additional sites? I know you mentioned in the queue about adding potentially two or three new sites. Does that grant cover those costs?

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Yeah. Thank you. Great question too. Yeah. The way the grant works, it's really designed to cover the cost of adding a certain number of additional subjects to the study. We've focused initially on five sites, which frankly, at the rates they're going, can be sufficient to add those additional subjects in a very reasonable timeframe.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We're going to look at whether there are other sites that we need to open as well. Right now, we're really happy with the pace of enrollment at the five sites, but we definitely have some flexibility to add some additional sites as well.

Ollie Heidel
Analyst at Brookline Capital Markets

Okay, great. R&D came in a little lower than last quarter. Should we expect that number to continue going forward, or should we see an uptick in that?

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Right now, thanks for asking for that clarification, by the way. Right now, the only ongoing study at this time is the Ovaprene study. As we were just talking about, the activities right now are really funded with the grant funding we receive.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

We do have sometimes, and MarDee kind of alluded to this, other costs associated with Ovaprene, and those were in, I think, the queue as well related to manufacturing, just other things that we're doing, obviously, to support the product and certain other activities that we might want to kind of lean into, even related to the study sometimes, like advertising, things like that. What you've seen in terms of those trends is really reflective of the fact that we don't have other ongoing studies at this time. Until we do, that's the kind of trend you should expect to continue to see until we have other studies going on at this time.

Ollie Heidel
Analyst at Brookline Capital Markets

Okay. Thank you. If I could ask one more. With Sildenafil Cream, you mentioned, I think, last quarter that you needed about $1 million to get the 503(b) operations going.

Ollie Heidel
Analyst at Brookline Capital Markets

Does that apply to the additional products, or will there be an additional cost?

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Oh, that's another great question. Yeah, that's very specific to Sildenafil. So that's really the cost associated with supporting our 503(b) manufacturer with the startup, tech transfer activities like that that are needed to produce GMP Sildenafil Cream product. There would be additional costs associated with production activities and tech transfer activities associated with the hormone therapy product. They're in a similar range as that, but it's because it's for those similar kinds of activities. It's basically to ensure that the manufacturer under GMP has the opportunity to do all the things that are required under GMP and has all of the right equipment and things like that. As we get closer, the DARE-HRT1, the hormone therapy product, is really targeted for next year.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

As we continue to progress on that and get closer, we'll be able to give even better guidance around that and what those costs are. Okay. Thank you. It's the same kind of ballpark, right? We're talking single-digit millions and not tens of millions.

Ollie Heidel
Analyst at Brookline Capital Markets

Okay. Great.

Operator

That concludes our Q&A session for today. I would like to turn the call back over to Sabrina Martucci Johnson for any additional or closing remarks.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Great. Thank you all for taking the time this afternoon, and special thanks for the really thoughtful questions. I'll close with basically the same comment I made up front. Repetition's important sometimes, which is that Daré is uniquely positioned to cut through the noise and deliver value to all of our stakeholders, women, healthcare providers, and investors.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Today, biopharmaceutical companies with relatively low-risk assets, a competitive advantage, and a path towards near-term revenue are positioned to offer upside. As I said upfront, we believe that is Daré today. I can't stress enough that Women's Health is ripe for returns. It has been so underfunded and fragmented. With our recently announced expanded business strategy, we believe we're uniquely positioned to deliver that value and returns to all of the stakeholders with this business model that I hope you will agree is nimble, allowing us to rapidly commercialize multiple products via multiple channels. Four on-market products will accelerate revenue generation and provide a path to profitability. We expect to start recording revenue in the fourth quarter of this year. The portfolio is compelling.

Sabrina Martucci Johnson
President and CEO at Daré Bioscience

Over the next months, as I've said, we look forward to providing updates regarding strategic partnerships and collaborations to facilitate access to our on-market brands for women across multiple channels. Thank you for listening today and for your support.

Operator

Thank you, everyone. That concludes today's call. Thank you all for joining. You may now disconnect. Have a nice day.

Analysts
    • MarDee Haring-Layton
      Chief Accounting Officer at Daré Bioscience
    • Douglas Chow
      Analyst at HC Wainwright
    • Analyst
    • Sabrina Martucci Johnson
      President and CEO at Daré Bioscience
    • Ollie Heidel
      Analyst at Brookline Capital Markets
Powered by Quartr